Cigna said it will move away from re­ceiv­ing drug re­bates, an opaque part of the US drug pric­ing for­mu­la that has drawn in­creased scruti­ny from fed­er­al and state law­mak­ers.

The health in­sur­er, which owns phar­ma­cy ben­e­fit man­ag­er Ex­press Scripts, said Mon­day that dis­counts will be avail­able up­front for ful­ly in­sured pa­tients in 2027, and that it will be the “stan­dard mod­el” for all cus­tomers be­gin­ning in 2028.

PBMs get dis­counts from drug­mak­ers in the form of re­bates when pa­tients fill pre­scrip­tions, but PBMs don't have to pass on those sav­ings to con­sumers. Drug­mak­ers ar­gue that these re­bates have caused their own costs to rise. PBMs will typ­i­cal­ly charge a high­er re­bate for more fa­vor­able prod­uct place­ment on their for­mu­la­ries.

Organon’s CEO has stepped down and the com­pa­ny’s stock tanked af­ter an in­ter­nal in­ves­ti­ga­tion found ev­i­dence of “im­prop­er” sales prac­tices for the con­tra­cep­tive im­plant Nex­planon.

Ac­cord­ing to the com­pa­ny, the board­'s au­dit com­mit­tee found that Organon asked some US whole­salers to buy more Nex­planon than need­ed at the end of sev­er­al quar­ters, which helped boost the com­pa­ny's re­sults.

“With­out these sales prac­tices, the com­pa­ny’s con­sol­i­dat­ed rev­enue for cer­tain of those pe­ri­ods would have fall­en short of the Com­pa­ny’s guid­ance and/or cer­tain ex­ter­nal rev­enue ex­pec­ta­tions," Organon said in a se­cu­ri­ties fil­ing.

The prac­tice, col­lo­qui­al­ly known as “chan­nel stuff­ing,” can make sales ap­pear ar­ti­fi­cial­ly high­er than they re­al­ly are.

In­tel­lia Ther­a­peu­tics has paused en­roll­ment and dos­ing in two clin­i­cal tri­als of its CRISPR ther­a­py, called nex-z, for the ge­net­ic dis­ease transthyretin amy­loi­do­sis (AT­TR), the com­pa­ny an­nounced Mon­day morn­ing.

In a call with in­vestors, CEO John Leonard said a pa­tient who re­ceived In­tel­lia’s ther­a­py on Sept. 30 went to the emer­gency room a few weeks lat­er af­ter ex­pe­ri­enc­ing ab­dom­i­nal pain. On Oct. 24, he was found to have grade 4 el­e­va­tions of liv­er transam­i­nas­es and biliru­bin — bio­mark­ers that can in­di­cate se­vere liv­er in­jury, ac­cord­ing to the com­pa­ny.

The pa­tient is a man in his ear­ly 80s who is cur­rent­ly sta­ble, but re­mains hos­pi­tal­ized. Leonard said the pa­tient had a high BMI, but that it was “pre­ma­ture” to sug­gest that any par­tic­u­lar sub­sets of pa­tients are at high­er risk. “Ob­vi­ous­ly we’re look­ing in­to that,” he added.

The FDA last week tran­si­tioned Mary Thanh Hai from act­ing to per­ma­nent di­rec­tor of the Of­fice of New Drugs, two peo­ple with knowl­edge of the move told End­points News.

Thanh Hai took over as act­ing OND di­rec­tor from Pe­ter Stein, who was pushed out of his po­si­tion in April as part of a wider re­duc­tion in force. OND is re­spon­si­ble for ap­prov­ing all new drugs.

Stein told End­points on Mon­day that he thought Thanh Hai was "a great choice — she’s high­ly ex­pe­ri­enced, an­a­lyt­ic and thor­ough, ex­treme­ly knowl­edge­able."

The FDA, CDER Di­rec­tor George Tid­marsh, and Thanh Hai did not im­me­di­ate­ly re­spond to re­quests for com­ment.